This study aims to evaluate the impact of the frequency of assessments on the variability over time, reliability, and compliance for the Parkinson's disease (PD) diary in patients with PD in whom medications do not provide adequate control of symptoms.
Eligibility
Sex
ALL
Min age
39 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria
* ≥39 to ≤70 years of age at signing of informed consent
* Diagnosis of clinically established PD as defined by the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for PD
* Marked levodopa responsiveness at screening per investigator's judgment (eg, an estimated ≥30% improvement of MDS-UPDRS Part III score in the off-medication versus on-medication state)
* A minimum of 3 years and a maximum of 10 years from time of PD diagnosis to the date of screening
* Receiving optimized and stable PD medical therapy for ≥1 month prior to screening or demonstrated intolerance to PD medications per investigator's judgment in agreement with the medical monitor
* ≥2 hours of average daily OFF-time assessed within 3 months of screening by PD diary or per investigator's judgment
* Hoehn and Yahr Stage of 1 to 3 while on PD medication assessed within 3 months of screening or at screening
* Normal cognition as determined by the investigator after review of relevant testing (eg, Montreal Cognitive Assessment score of ≥26, or ≥22 if no significant cognitive impairment as determined by neuropsychological testing)
Exclusion Criteria:
* PD with risk of recurrent falls or only tremor-based symptoms
* Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis, or clinical features suggestive of a neurodegenerative disease other than PD such as Alzheimer's disease
* Any available evidence inconsistent with dopamine deficiency (eg, 18F-DOPA positron emission tomography \[PET\] or dopamine transporter single-photon emission computed tomography \[DAT-SPECT\] imaging if performed)
* Moderately severe dyskinesia per investigator's judgment
* Receiving dopamine receptor-blocking agents, including typical neuroleptics, prochlorperazine, and metoclopramide at the time of screening or within 3 months prior to screening
* Treatment with intrajejunal or subcutaneous infusion therapies for PD within 2 months of screening
* History of gene therapy or cell therapy
* Prior surgical or radiation therapy to the brain, including deep brain stimulation and lesion therapy, or prior history of intradural spinal cord surgery
* Receipt of another investigational therapy or device within 2 years of screening unless approved by the medical monitor
Primary outcome measure(s)
Change in Good ON-time as measured by the PD Diary. — Baseline, 3, 6, 12, 18 and 24 months. Standard deviation of change in ON-time without troublesome dyskinesia (Good ON-time) as measured by the PD diary.
Individual participant variability for ON-time without troublesome dyskinesia (Good ON-time) as measured by the PD diary. — Baseline, 3, 6, 12, 18 and 24 months. Within-subject coefficient of variation for ON-time without troublesome dyskinesia (Good ON-time) as measured by the PD diary.
Proportion of valid PD Diaries. — Baseline, 3, 6, 12, 18 and 24 months. Proportion of valid PD Diaries.
Trial sites (34)
Facility
City
Region
Status
Mayo Clinic Neurology
Scottsdale
Arizona
David Geffen School of Medicine University of California Los Angeles
Los Angeles
California
University of California, Irvine
Orange
California
University of Colorado
Aurora
Colorado
Movement Disorders Center of Boca Raton
Boca Raton
Florida
University of Miami Health System
Miami
Florida
Parkinson's Disease and Movement Disorders Center at Northwestern University Feinberg School of Medicine
Chicago
Illinois
University of Kansas Medical Center
Kansas City
Kansas
University of Louisville
Louisville
Kentucky
Tufts Medical Center
Boston
Massachusetts
Mount Sinai West
New York
New York
Weill Cornell Medicine - New York Presbyterian Hospital
New York
New York
University of Rochester Medical Center
Rochester
New York
Cleveland Clinic
Cleveland
Ohio
Vanderbilt University Medical Center
Nashville
Tennessee
Evergreen Health Medical Center
Kirkland
Washington
Toronto Western Hospital
Toronto
Ontario
Dkd Wiesbaden
Wolfach
Baden-Wurttemberg
Klinikum der Universität München - Campus Grosshadern
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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